UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008253 |
|---|---|
| Receipt number | R000009695 |
| Scientific Title | A Randomized Clinical Trial of Transcatheter Arterial Infusion (TAI) appending to Radio Frequency Ablation Therapy for Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2012/06/25 |
| Last modified on | 2013/01/24 14:18:16 |
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Basic information
Public title
A Randomized Clinical Trial of Transcatheter Arterial Infusion (TAI) appending to Radio Frequency Ablation Therapy for Hepatocellular Carcinoma
Acronym
Transcatheter Arterial Infusion (TAI) appending to Radio Frequency Ablation Therapy for Hepatocellular Carcinoma
Scientific Title
A Randomized Clinical Trial of Transcatheter Arterial Infusion (TAI) appending to Radio Frequency Ablation Therapy for Hepatocellular Carcinoma
Scientific Title:Acronym
Transcatheter Arterial Infusion (TAI) appending to Radio Frequency Ablation Therapy for Hepatocellular Carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular Carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether transacatheter arterial infusion of CDDP suppress the recurrence rate of HCC curatively treated by radiofrequency ablation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recurrence-free survival, recurrence rate(local, distant)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
RFA only.
Interventions/Control_2
Transcatheter arterial infusion of CDDP(65mg/m2) before RFA.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or clinically diagnosed hepatocellular carcinoma.
2)Patients who do not want surgery or other percutaneous local therapy. History of local ablation is limited up to two times.
3)With measurable tumor in the liver, and without extrahepatic metastasis.
4)Performance Status:0-1
5)Child-Pugh:A or B
6)A case the function of the main organ (marrow, kidney, heart) is maintained enough and to meet a standard of the following clinical inspection.
1)WBC:more than 3000/mm3
2)Platelet:more than 5x104/mm3
3)Hb:more than 9.5g/dL
4)serum creatinine:less than 1.2mg/dL
5)BUN:less than 25mg/dL
6)Prothrombin time:more than 50%
7)Total bilirubin:<3.0mg/dL
Key exclusion criteria
1)Severe complications excluding cirrhosis.
2)Active other cancers.
3)History of severe allergy.
4)Pregnant or maybe pregnant, breast-feeding.
5)A case have plan to use interferon during this study period.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sinpei Sato |
Organization
Kyoundo Hospital
Division name
gastroenterology and hepatology
Zip code
Address
1-8 Kandasurugadai, Chiyoda-Ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoundo Hospital
Division name
gastroenterology and hepatology
Zip code
Address
1-8 Kandasurugadai, Chiyoda-Ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Kyoundo Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 25 | Day |
Last modified on
| 2013 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009695
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
